At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 4 enrolled

Drug / intervention

lamotrigine (brand Lamictal) +1 moredrug

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02404168

NCT02404168Phase 4Completed

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Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients

University of Maryland, Baltimore·interventional·Posted Mar 31, 2015·Updated Aug 19, 2019

In Brief

A Phase 4 clinical trial evaluating lamotrigine (brand Lamictal) and lamotrigine (generic Teva) for Epilepsy. Completed, enrolled 4 participants across 1 site.

Detailed Summary

The prior BEEP study involved patients being switched between brand and generic in a very structured manner. Other secondary comparisons were also made (i.e. any differences in adverse effects and seizure control). Some subjects were more disparate than other, in terms of generic being similar to brand. In this follow up study, BEEP subjects that showed disparate results will be tested again to assess reproducibility of disparate results.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsEpilepsy

CountriesUnited States

Collaborators--

Timeline

Phase 4CompletedFinished

201520162017201820192020202120222023202420252026

First PostedMar 2015

Enrollment StartJul 2015

Primary CompletionJan 2016

Study CompletionApr 2016

TodayJul 2026

First PostedMar 31, 2015

Enrollment StartJul 7, 2015

Primary CompletionJan 18, 2016

Study CompletionApr 6, 2016

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 11.3 years ago

Interventions

lamotrigine (brand Lamictal)drug

an anti-epileptic drug (brand)

lamotrigine (generic Teva)drug

an anti-epileptic drug (brand)